Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Niti-S Esophageal Stent; Esophageal TTS Stent

K-Number: K243619 · 2025-10-30

ApplicantTaewoong Medical Co., Ltd.
Decision Date2025-10-30
Product CodeESW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Niti-S Esophageal Stent; Esophageal TTS Stent is a medical device manufactured by Taewoong Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-10-30 under approval number K243619. The device is classified under product code ESW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Niti-S Esophageal Stent; Esophageal TTS Stent?

Niti-S Esophageal Stent; Esophageal TTS Stent is a medical device that received FDA 510(k) clearance on 2025-10-30. It is manufactured by Taewoong Medical Co., Ltd.. The 510(k) number is K243619.

When was Niti-S Esophageal Stent; Esophageal TTS Stent approved by the FDA?

Niti-S Esophageal Stent; Esophageal TTS Stent received FDA 510(k) clearance on 2025-10-30, under approval number K243619.

What company makes Niti-S Esophageal Stent; Esophageal TTS Stent?

Niti-S Esophageal Stent; Esophageal TTS Stent is manufactured by Taewoong Medical Co., Ltd..

What is the FDA product code for Niti-S Esophageal Stent; Esophageal TTS Stent?

The FDA product code for Niti-S Esophageal Stent; Esophageal TTS Stent is ESW.

Other Devices by Taewoong Medical Co., Ltd.

K211706Esophageal TTS Stent K221482Esophageal TTS Stent K221071Niti-S Biliary Slim M Stent K223067Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent K223626Niti-S Biliary Speed D Stent K223256Optimos™ Cystotome

View all 10 devices →

Related Devices (Code: ESW)

K162717Evolution Esophageal Stent System – Partially CoveredCook Ireland, Ltd. K180144Agile Esophageal Stent SystemBoston Scientific Corporation K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. K182910Segmented Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. K200860HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN)M.I.Tech Co., Ltd. K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑